DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/28/2026 has been entered.
Response to Amendment
Applicant’s amendments filed on 01/28/2026 have been fully considered. Claims 1-12 are pending in this application. Claims 1-10 are amended. Claims 11-12 are newly added.
Response to Arguments
Applicant’s arguments with respect to amended independent claims 1 and 5 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Mallaby (Publication No. US 2010/0204712 A1) in view of Ross et al. (Publication No. US 2010/0191178 A1) and Zadno-Azizi (Publication No. US 2002/0052638 A1).
Regarding claim 1, Mallaby teaches a system for facilitating aspiration of a thrombus within vasculature (system that aspirates clots in the neurovasculature; Paragraph 0040; Abstract; Figure 1), the system comprising: a flexible catheter comprising an open, atraumatic distal tip (catheter 104 is flexible and has a soft, atraumatic tip to navigate neurovasculature; Paragraph 0066; Figure 4); and a vacuum source configured to generate a suction output (vacuum means 38 generates a suction force; Paragraph 0069; Figure 1), wherein, when in use, the vacuum source is in fluid communication with a lumen of the flexible catheter and is connected through a tubing directly to a proximal end of the flexible catheter to (i) the proximal end of the flexible catheter or (ii) the proximal end of the flexible catheter and a second catheter positioned within the flexible catheter (vacuum means 38 is connected to tubing that is directly connected to the proximal end of the catheter 104; Paragraph 0069; Figure 1).
Mallaby does not teach the vacuum source is in fluid communication with a lumen of the flexible catheter and is connected through a tubing indirectly through a valve to (i) the proximal end of the flexible catheter or (ii) the proximal end of the flexible catheter and a second catheter positioned within the flexible catheter, wherein the valve is configured to control at least one of a change in suction pressure or a flow of the suction output, wherein the change in suction pressure comprises: a first intensity level having a first suction pressure or a second intensity level having a second suction pressure.
However, Ross teaches the vacuum source is in fluid communication with a lumen of the flexible catheter and is connected through a tubing indirectly through a valve (vacuum pulsing device 156 is a valve that controls the vacuum that is delivered to the catheter produced by the vacuum pump 108 – pump 108 is indirectly connected through line 152 to catheter with valve 156 inbetween; Paragraph 0066; Figure 1) to (i) the proximal end of the flexible catheter (vacuum source 108 delivers vacuum to the proximal end of catheter; Figure 1; Paragraph 0066) or (ii) the proximal end of the flexible catheter and a second catheter positioned within the flexible catheter, wherein the valve is configured to control at least one of a change in suction pressure or a flow of the suction output (vacuum pulsing device 156 is used to change the suction pressure or flow of suction output; Paragraph 0066; Figure 1), wherein the change in suction pressure comprises: a first intensity level having a first suction pressure or a second intensity level having a second suction pressure (oscillating pressure with square waves/step functions or vacuum off function of vacuum pulsing device 156 switches vacuum pressure from a first pressure having a higher first suction intensity to a second pressure having a lower suction intensity at zero vacuum; Paragraph 0064-0066; Figure 1-3).
Mallaby and Ross are both considered to be analogous to the claimed invention because they are in the same field of aspiration/vacuum devices for medical treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mallaby to incorporate the teachings of Ross such that the aspiration pump of Mallaby is connected to the control console and circuitry with the vacuum pulsing device of Ross, the vacuum pulsing device between the catheter and the pump of Mallaby. This allows for the user to control the change in vacuum intensities based on the desired treatment (Ross; Paragraph 0064-0066 and 0092).
The combination of Mallaby in view of Ross does not teach wherein the first intensity level having the first suction pressure less than -760 mmHg.
However, Zadno-Azizi teaches comprising a suction pressure that is approximately 3-30 inches of mercury, or about 76.2 mmHg to 762 mmHg (Paragraph 0200; Figure 41).
Mallaby in view of Ross and Zadno-Azizi are both considered to be analogous to the claimed invention because they are in the same field of emboli aspiration. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mallaby in view of Ross to incorporate the teachings of Zadno-Azizi and have the negative pressure range of Zadno-Azizi as the first intensity of the first pressure produced by the aspirating means of Mallaby in view of Ross. This allows for the aspiration of larger emboli into the system (Zadno-Azizi; Paragraph 0200).
The combination of Mallaby in view of Ross and Zadno-Azizi further teaches wherein the first intensity level having the first suction pressure less than -760 mmHg; or the second intensity level having the second suction pressure of 0 to -350 mmHg (square wave pattern of vacuum pulses from the device of Mallaby in view of Ross can have a first suction pressure with a first intensity level of less than -760 mmHg, as taught by Zadno-Azizi, and a second suction pressure with a second intensity level of between 0 and -350 mmHg, as taught by Ross; Zadno-Azizi; Figure 41; Paragraph 0200; Ross; second pressure with a second intensity of zero vacuum; Paragraph 0064; Figures 2-3; see combination above).
Regarding claim 2, Mallaby in view of Ross and Zadno-Azizi teaches the system of claim 1. The combination of Mallaby in view of Ross and Zadno-Azizi further teaches wherein the vacuum source comprises one of an automated suction device or a vacuum pump (Mallaby; aspiration means 38 is a vacuum pump 38; Figure 1; Paragraph 0081).
Regarding claim 3, Mallaby in view of Ross and Zadno-Azizi teaches the system of claim 1. The combination of Mallaby in view of Ross and Zadno-Azizi does not teach wherein the vacuum source comprises at least one of a manual suction device or a syringe.
However, Zadno-Azizi teaches wherein the vacuum source comprises at least one of a manual suction device or a syringe (bulb 821 is connected to system to aspirate liquid carrying emboli 818; Figure 41; Paragraph 0200).
Mallaby in view of Ross and Zadno-Azizi are both considered to be analogous to the claimed invention because they are in the same field of emboli aspiration. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mallaby in view of Ross and Zadno-Azizi to incorporate the teachings of Zadno-Azizi and have the bulb of Zadno-Azizi be the aspirating means of Mallaby in view of Ross and Zadno-Azizi. This allows for the aspiration of larger emboli into the bulb (Zadno-Azizi; Paragraph 0200).
Regarding claim 4, Mallaby in view of Ross and Zadno-Azizi teaches the system of claim 1. The combination of Mallaby in view of Ross and Zadno-Azizi further teaches wherein the valve is configured to open and close to cyclically change the suction pressure at a distal end of the flexible catheter or the second catheter positioned within the flexible catheter (Ross; oscillating pressure with square waves/step functions or vacuum off function of vacuum pulsing device 156 switches vacuum pressure from a first pressure having a higher first suction intensity to a second pressure having a lower suction intensity at zero vacuum – oscillating vacuum pulses will change the suction pressure at distal end of the catheter; Paragraph 0064-0066; Figure 1-3; see rejection of claim 1 above).
Regarding claim 12, Mallaby in view of Ross and Zadno-Azizi teaches the system of claim 1. The combination of Mallaby in view of Ross and Zadno-Azizi further teaches wherein the suction output is configured to be generated or changed at a location between the vacuum source and a distal end of the flexible catheter or the second catheter (Ross; vacuum pulse device 156 generates oscillating pressures at a location between the vacuum pump 108 and the distal end of the catheter; Figure 1; see rejection of claim 5 above).
Claim(s) 5-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mallaby (Publication No. US 2010/0204712 A1) in view of Ross et al. (Publication No. US 2010/0191178 A1).
Regarding claim 5, Mallaby teaches a system for facilitating aspiration of a thrombus within vasculature (system that aspirates clots in the neurovasculature; Paragraph 0040; Abstract; Figure 1), the system comprising: a flexible catheter comprising an open, atraumatic distal tip (catheter 104 is flexible and has a soft, atraumatic tip to navigate neurovasculature; Paragraph 0066; Figure 4); and a suction device configured to facilitate aspiration (aspiration means 38 configured to facilitate aspiration to catheter 104; Figure 1; Paragraph 0069 and 0081), the suction device comprising: a vacuum source (aspiration means 38 is a vacuum pump; Figure 1; Paragraph 0081); and suction tubing (suction tubing connects pump with canister 36 to catheter 104; Figure 1). Mallaby does not teach wherein the suction device is configured to generate at least one cyclical suction output.
However, Ross teaches wherein the suction device is configured to generate at least one cyclical suction output (oscillating pressure with square waves/step functions of vacuum pulsing device 156 switches vacuum pressure from a first pressure having a higher first suction intensity to a second pressure having a lower suction intensity at zero vacuum; Paragraph 0064-0066; Figure 1-3).
Mallaby and Ross are both considered to be analogous to the claimed invention because they are in the same field of aspiration/vacuum devices for medical treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mallaby to incorporate the teachings of Ross such that the aspiration pump of Mallaby is connected to the control console and circuitry with the vacuum pulsing device of Ross, the vacuum pulsing device between the catheter and the pump of Mallaby. This allows for the user to control the change in vacuum intensities based on the desired treatment (Ross; Paragraph 0064-0066 and 0092).
Regarding claim 6, Mallaby in view of Ross teaches the system of claim 5. The combination of Mallaby in view of Ross further teaches wherein the vacuum source, when in use, is in fluid communication with a lumen of the flexible catheter (Mallaby; vacuum means 38 is connected to tubing that is directly connected to the proximal end of the catheter 104; Paragraph 0069; Figure 1) and is connected through a tubing directly to a proximal end of the flexible catheter or indirectly through a valve (Ross; vacuum pulsing device 156 is a valve that controls the vacuum that is delivered to the catheter produced by the vacuum pump 108 – pump 108 is indirectly connected through line 152 to catheter with valve 156 inbetween; Paragraph 0066; Figure 1) to (i) the proximal end of the flexible catheter (Ross; vacuum source 108 delivers vacuum to the proximal end of catheter; Figure 1; Paragraph 0066) or (ii) the proximal end of the flexible catheter and a second catheter positioned within the flexible catheter.
Regarding claim 7, Mallaby in view of Ross teaches the system of claim 5. The combination of Mallaby in view of Ross further teaches wherein the at least one cyclical suction output comprises at least one repetitive cyclical suction output (Ross; oscillating pressure with square waves/step functions is repetitive; Paragraph 0064-0066; Figure 1-3).
Regarding claim 8, Mallaby in view of Ross teaches the system of claim 5. The combination of Mallaby in view of Ross further teaches wherein the flexible catheter comprises a connector, a hemostatic valve, a microcatheter, a distal access microcatheter, a guide catheter, a shuttle catheter, a venous catheter, a delivery catheter, a balloon guide catheter, a ventriculostomy catheter, an endoscope, a laparoscope, or combinations thereof (Mallaby; microcatheter for neurovascular access; Abstract).
Regarding claim 9, Mallaby in view of Ross teaches the system of claim 5. The combination of Mallaby in view of Ross further teaches wherein the at least one cyclical suction output is configured to be generated or changed at a location between the vacuum source and a distal end of the flexible catheter (Ross; vacuum pulse device 156 generates oscillating pressures at a location between the vacuum pump 108 and the distal end of the catheter; Figure 1; see rejection of claim 5 above).
Regarding claim 11, Mallaby in view of Ross teaches the system of claim 5. The combination of Mallaby in view of Ross further teaches wherein the suction device is a negative suction device (Mallaby; suction device is a negative suction device; Figure 1; Paragraph 0069-0070 and 0081).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mallaby (Publication No. US 2010/0204712 A1) in view of Ross et al. (Publication No. US 2010/0191178 A1), as applied to claim 7 above, and further in view of Zadno-Azizi (Publication No. US 2002/0052638 A1).
Regarding claim 10, Mallaby in view of Ross teaches the system of claim 7. The combination of Mallaby in view of Ross further teaches wherein the at least one repetitive cyclical suction output comprises at least two different intensity levels (Ross; oscillating pressure with square waves/step functions of vacuum pulsing device 156 switches vacuum pressure from a first pressure having a higher first suction intensity to a second pressure having a lower suction intensity at zero vacuum; Paragraph 0064-0066; Figure 1-3), with a first intensity level having a first suction pressure and a second intensity level having a second suction pressure of 0 to -350 mmHg (Ross; second pressure with a second intensity of zero vacuum; Paragraph 0064; Figures 2-3; see rejection of claim 5 above), wherein a first intensity level of the at least two different intensity levels has a first duration, and wherein a second intensity level of the at least two different intensity levels has a second duration (Ross; first intensity level has a first duration and second intensity level has a second duration; Figures 2-3). The combination of Mallaby in view of Ross does not teach wherein the first intensity level having the first suction pressure less than -760 mmHg.
However, Zadno-Azizi teaches comprising a suction pressure that is approximately 3-30 inches of mercury, or about 76.2 mmHg to 762 mmHg (Paragraph 0200; Figure 41).
Mallaby in view of Ross and Zadno-Azizi are both considered to be analogous to the claimed invention because they are in the same field of emboli aspiration. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Mallaby in view of Ross to incorporate the teachings of Zadno-Azizi and have the negative pressure range of Zadno-Azizi as the first intensity of the first pressure produced by the aspirating means of Mallaby in view of Ross. This allows for the aspiration of larger emboli into the system (Zadno-Azizi; Paragraph 0200).
The combination of Mallaby in view of Ross and Zadno-Azizi further teaches wherein the first intensity level having the first suction pressure less than -760 mmHg and the second intensity level having the second suction pressure of 0 to -350 mmHg (square wave pattern of vacuum pulses from the device of Mallaby in view of Ross can have a first suction pressure with a first intensity level of less than -760 mmHg, as taught by Zadno-Azizi, and a second suction pressure with a second intensity level of between 0 and -350 mmHg, as taught by Ross; Zadno-Azizi; Figure 41; Paragraph 0200; Ross; second pressure with a second intensity of zero vacuum; Paragraph 0064; Figures 2-3; see combination above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781